Recall archive / FDA device enforcement
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. — FDA record Z-0479-2025
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
- Reason
- Potential failure of affected units to recharge the battery of the oxygen concentrators.
- Classification
- Class II
- Recalling firm
- Caire, Inc.
- Quantity
- 23 concentrators
- Agency-reported status
- Completed
- Source record identifier
- Z-0479-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 27, 2024
- Recall initiation date
- Oct 4, 2024
- Center classification date
- Nov 15, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.